Recipharm says serialization project for Abbott a success

Recipharm says it has completed an initiative - started last April - to help Abbott meet Korea's serialization requirements for medicines.

Last year, Korea's Ministry of Health and Welfare announced phased pharmaceutical serialization deadlines - starting at the beginning of this year.

As of January 1, 2015, 30 per cent of medicinal products (by sales) and 100 per cent of psychotropic medicines, biologic drugs and products that are flammable or explosive needed to be serialised. The deadline for serializing all pharma products is January 1, 2016, and in that month a requirement also comes into effect for reporting of serialized product supply.

Recipharm said it had helped Abbott mark products with "a datamatrix code, including serial number, with full compliance with complex regulations, similar to foreseen EU rules" but "differing markedly from Chinese serialisation."

The system was applied to a blister packaging line and validation batches are now being manufactured and released and will be shipped to Korea mid-March 2015.

The country has indicated that it plans to carry out a series of supply chain traceability pilots this year to gauge the feasibility of eventually implementing a full track-and-trace system for Korea.

"Once again, our serialization platform solution has proved the extent of its adaptability and resourcefulness for differing geographic and multi-country regulatory requirements," said Stephane Guisado, general manager at Recipharm in Fontaine, France.

"Indeed, in this case, it ensured that our customer complied in full with the relevant serialisation regulations set down by Korea," he added.


Image courtesy of Shutterstock / Bozena Fulawka